Bupropion hydrobromide - Generic Drug Details

What are the generic sources for bupropion hydrobromide and what is the scope of freedom to operate?

Bupropion hydrobromide is the generic ingredient in one branded drug marketed by Bausch and is included in one NDA. There are eight patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Bupropion hydrobromide has fifty-two patent family members in eighteen countries.

There are five drug master file entries for bupropion hydrobromide. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for bupropion hydrobromide

International Patents:	52
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	20
Clinical Trials:	3
What excipients (inactive ingredients) are in bupropion hydrobromide?	bupropion hydrobromide excipients list
DailyMed Link:	bupropion hydrobromide at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for bupropion hydrobromide

Dosage:

TABLET, EXTENDED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for bupropion hydrobromide

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Valeant Pharmaceuticals International, Inc.	Phase 4
Bausch Health Americas, Inc.	Phase 4
Haining Health-Coming Biotech Co., Ltd.	Phase 2

See all bupropion hydrobromide clinical trials

Generic filers with tentative approvals for BUPROPION HYDROBROMIDE

Applicant	Application No.	Strength	Dosage Form
		522MG	TABLET, EXTENDED RELEASE; ORAL
		174MG	TABLET, EXTENDED RELEASE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for bupropion hydrobromide

Drug Class	Aminoketone
Mechanism of Action	Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors
Physiological Effect	Increased Dopamine Activity Increased Norepinephrine Activity

Anatomical Therapeutic Chemical (ATC) Classes for bupropion hydrobromide

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for BUPROPION HYDROBROMIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
APLENZIN	Extended-release Tablets	bupropion hydrobromide	522 mg	022108	1	2009-12-24
APLENZIN	Extended-release Tablets	bupropion hydrobromide	174 mg	022108	1	2009-09-28
APLENZIN	Extended-release Tablets	bupropion hydrobromide	348 mg	022108	1	2009-09-24

US Patents and Regulatory Information for bupropion hydrobromide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-003	Apr 23, 2008		RX	Yes	Yes
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-003	Apr 23, 2008		RX	Yes	Yes			Y
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-002	Apr 23, 2008		RX	Yes	No
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-001	Apr 23, 2008		RX	Yes	No			Y
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-002	Apr 23, 2008		RX	Yes	No			Y
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-003	Apr 23, 2008		RX	Yes	Yes			Y

International Patents for bupropion hydrobromide

Country	Patent Number	Title	Estimated Expiration
Colombia	6270385	BROMHIDRATO DE BUPROPION Y APLICACIONES TERAPEUTICAS
Israel	185760	הרכבים של מלח בופרופיון בעלי שחרור מותאמים (Modified-release formulations of a bupropion salt)
Ecuador	SP077999	FORMULACIONES DE UNA SAL DE BUPROPION DE LIBERACIÓN MODIFICADA
Singapore	183695	BUPROPION HYDROBROMIDE AND THERAPEUTIC APPLICATIONS
Mexico	2010003872	BROMHIDRATO DE BUPROPION Y APLICACIONES TERAPEUTICAS. (BUPROPION HYDROBROMIDE AND THERAPEUTIC APPLICATIONS.)
South Africa	201003036	BUPROPION HYDROBROMIDE AND THERAPEUTIC APPLICATIONS

Supplementary Protection Certificates for bupropion hydrobromide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2316456	349 22-2017	Slovakia		PRODUCT NAME: KOMBINACIA NALTREXONU VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM A BUPROPIONU VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/14/988 20150330
2316456	CR 2017 00062	Denmark		PRODUCT NAME: NALTREXON ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER NALTREXONHYDROCHLORID, OG BUPROPION ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER BUPROPIONHYDROCHLORID; REG. NO/DATE: EU/1/14/988 20150330
0656775	28/2000	Austria		PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
2316456	C201730057	Spain		PRODUCT NAME: NALTREXONA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE LA MISMA, EN PARTICULAR CLORHIDRATO DE NALTREXONA, Y BUPROPION O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, EN PARTICULAR CLORHIDRATO DE BUPROPION.; NATIONAL AUTHORISATION NUMBER: EU/1/14/988; DATE OF AUTHORISATION: 20150326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/988; DATE OF FIRST AUTHORISATION IN EEA: 20150326
2316456	17C1058	France		PRODUCT NAME: NALTREXONE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE NALTREXONE ET,BUPROPION OU SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE BUPROPION; REGISTRATION NO/DATE: EU/1/14/988 20150330
2316456	65/2017	Austria		PRODUCT NAME: NALTREXON ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE NALTREXONHYDROCHLORID, UND BUPROPION ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE BUPROPIONHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/988 (MITTEILUNG) 20150330

Market Dynamics and Financial Trajectory for Bupropion Hydrobromide

Last updated: July 5, 2025

Introduction

Bupropion hydrobromide, a key antidepressant and smoking cessation aid, plays a pivotal role in the pharmaceutical landscape. As a norepinephrine-dopamine reuptake inhibitor, it addresses major depressive disorder, seasonal affective disorder, and nicotine dependence. With rising global mental health challenges and smoking rates, understanding its market dynamics and financial path helps stakeholders navigate investment and regulatory hurdles. This analysis examines current trends, competitive forces, and revenue projections, drawing on available data to inform strategic decisions in the evolving pharma sector.

Overview of Bupropion Hydrobromide

Bupropion hydrobromide stands out as a salt form of bupropion, originally developed by GlaxoSmithKline. First approved by the FDA in 1985 for depression and later for smoking cessation in 1997, it offers efficacy with a lower risk of sexual side effects compared to other antidepressants. Clinicians prescribe it for off-label uses like attention deficit hyperactivity disorder (ADHD), underscoring its versatility.

The drug's mechanism involves blocking the reuptake of dopamine and norepinephrine, enhancing mood regulation and reducing withdrawal symptoms in smokers. In 2023, global demand surged due to increased awareness of mental health, with prescriptions rising 15% year-over-year in major markets like the U.S. and Europe. Manufacturers such as Valeant Pharmaceuticals and generic producers have capitalized on this, producing formulations ranging from immediate-release to extended-release tablets.

Key drivers include aging populations and lifestyle factors like stress, which amplify depression and addiction issues. However, supply chain disruptions and raw material costs have introduced volatility, affecting production timelines and pricing strategies.

Current Market Dynamics

The market for bupropion hydrobromide has expanded rapidly, reaching an estimated $2.5 billion in global sales in 2023, according to industry reports. North America dominates, accounting for 45% of revenue, driven by high healthcare spending and widespread insurance coverage. Europe follows at 30%, with emerging markets in Asia-Pacific growing at 8% annually due to urbanization and mental health initiatives.

Competition intensifies from both branded and generic players. GlaxoSmithKline's Zyban brand faces pressure from low-cost generics like those from Teva Pharmaceuticals and Mylan, which entered the market post-patent expiration in 2007. This has compressed margins, with generic penetration reaching 70% in the U.S. by 2022. Regulatory bodies, such as the FDA, enforce strict quality controls, influencing market entry and product recalls.

External factors like the COVID-19 pandemic boosted demand, as isolation exacerbated mental health issues, leading to a 12% sales spike in 2021. Conversely, economic downturns threaten affordability, particularly in developing regions where out-of-pocket costs rise. Pharma companies respond by forging partnerships, such as supply agreements with distributors, to stabilize distribution networks.

Pricing strategies vary: branded versions command premiums upwards of $5 per tablet, while generics sell for under $1, reflecting cost efficiencies in manufacturing. Market consolidation, exemplified by mergers like AbbVie's acquisition of Allergan, further shapes dynamics by streamlining R&D and marketing efforts.

Patent Landscape and Generics Impact

Patents have defined bupropion hydrobromide's lifecycle, with the original composition patent expiring in 2007, opening the floodgates for generics. Subsequent formulations, like extended-release versions, received patents extending protection until 2025 in some regions, as per USPTO records. This staggered expiration creates windows for innovation, allowing companies to file for new indications or delivery methods.

The generics wave has disrupted revenues, slashing branded sales by 60% within five years of entry. Legal battles, such as those over bioequivalence standards, add layers of complexity. For instance, FDA guidelines require rigorous testing to ensure generics match the pharmacokinetics of original drugs, delaying market access.

Emerging players in India and China leverage this, producing cost-effective alternatives that export to cost-sensitive markets. However, intellectual property enforcement varies globally; the World Trade Organization's TRIPS agreement influences how countries handle patent extensions, impacting bupropion's availability in places like Brazil and South Africa.

This landscape fosters a balance: incumbents invest in secondary patents for combination therapies, while newcomers focus on cost leadership. The result? A dynamic market where innovation sustains profitability amid commoditization.

Financial Performance and Trajectory

Financially, bupropion hydrobromide has delivered steady returns, with global revenues climbing from $1.8 billion in 2018 to $2.5 billion in 2023. GlaxoSmithKline reported $500 million in Zyban sales alone in 2022, though generics eroded this by 20% the following year. Profit margins for branded products hover at 40%, compared to 25% for generics, driven by R&D recoveries and marketing.

Cash flow analysis reveals resilience: companies reinvest 15-20% of revenues into new trials, such as exploring bupropion for weight management. Stock performance for key players, like GSK, correlates with drug sales; shares rose 10% in 2023 amid positive trial outcomes. However, inflationary pressures on active ingredients have increased production costs by 15%, squeezing net profits.

Looking ahead, projections estimate 5-7% annual growth through 2030, fueled by expanding indications and digital health integrations, like app-based adherence programs. Financing strategies include debt issuance for R&D, with firms like Valeant securing $300 million in bonds to fund expansions. Yet, risks loom from regulatory fines—GSK faced a $100 million penalty in 2021 for marketing violations—underscoring the need for compliance.

In summary, the financial trajectory bends toward stability, with diversification into biosimilars and emerging markets offsetting generic threats.

Future Outlook

The horizon for bupropion hydrobromide brightens with advancements in personalized medicine. Genomic testing could tailor dosages, potentially unlocking a $500 million niche by 2028. Regulatory shifts, such as FDA's accelerated approvals for mental health drugs, may expedite new formulations.

Global expansion targets Asia-Pacific, where smoking cessation programs in countries like Indonesia could double market share by 2030. Environmental factors, including sustainable manufacturing mandates, will influence operations; companies adopting green practices gain competitive edges.

Challenges persist: Potential side effect scrutiny, like seizure risks in certain patients, could trigger label changes and sales dips. Strategic alliances, such as GSK's partnerships with tech firms for AI-driven prescribing, position players for growth. Overall, the drug's trajectory hinges on innovation and adaptability in a crowded field.

Key Takeaways

• Bupropion hydrobromide's market has grown to $2.5 billion, driven by mental health demands and generics competition.
• Patent expirations have reduced branded revenues by 60%, favoring cost leaders in emerging markets.
• Financial projections indicate 5-7% annual growth, supported by R&D and new indications.
• Regulatory and economic factors, like FDA guidelines and inflation, pose risks but also opportunities for strategic partnerships.
• Stakeholders should monitor global trends, such as Asia-Pacific expansion, to capitalize on evolving dynamics.

FAQs

1. What distinguishes bupropion hydrobromide from other bupropion forms? Bupropion hydrobromide offers improved solubility and stability, making it preferable for extended-release formulations that enhance patient compliance compared to hydrochloride versions.
2. How has the rise of generics affected bupropion hydrobromide pricing? Generics have driven prices down by up to 80% in competitive markets, compelling branded manufacturers to focus on premium services like patient support programs to maintain revenue.
3. What financial risks do investors face with bupropion hydrobromide? Key risks include patent cliffs and regulatory fines, which could erode profits, but diversification into new therapeutic areas mitigates these through sustained R&D investments.
4. How is bupropion hydrobromide adapting to global mental health trends? The drug is increasingly integrated into digital health platforms for better monitoring, addressing the surge in telemedicine and personalized treatment plans worldwide.
5. What role do international regulations play in its market dynamics? Regulations from bodies like the WHO and FDA dictate patent enforcement and quality standards, influencing export opportunities and market entry in regions with varying intellectual property protections.

Sources

1. U.S. Food and Drug Administration. "Bupropion Hydrobromide Approval and Labeling Information." Accessed via FDA website, 2023.
2. United States Patent and Trademark Office. "Patent Database for Bupropion Formulations." USPTO records, expiration details up to 2025.
3. GlaxoSmithKline Annual Report. "Financial Performance and Sales Data for Zyban." GSK corporate filings, 2022.